The following data is part of a premarket notification filed by Kay Elemetrics Corp. with the FDA for 7100 Swallowing Workstation.
| Device ID | K954798 |
| 510k Number | K954798 |
| Device Name: | 7100 SWALLOWING WORKSTATION |
| Classification | Monitor, Esophageal Motility, And Tube |
| Applicant | KAY ELEMETRICS CORP. 2 BRIDGEWATER LN. Lincoln Park, NJ 07035 -1488 |
| Contact | William D Harbeson |
| Correspondent | William D Harbeson KAY ELEMETRICS CORP. 2 BRIDGEWATER LN. Lincoln Park, NJ 07035 -1488 |
| Product Code | KLA |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-18 |
| Decision Date | 1996-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333242023 | K954798 | 000 |
| 04961333231089 | K954798 | 000 |
| 04961333231072 | K954798 | 000 |
| 04961333230495 | K954798 | 000 |
| 04961333230471 | K954798 | 000 |
| 04961333230464 | K954798 | 000 |
| 04961333230457 | K954798 | 000 |
| 04961333230440 | K954798 | 000 |
| 04961333230433 | K954798 | 000 |
| 04961333230426 | K954798 | 000 |
| 04961333229956 | K954798 | 000 |
| 04961333229949 | K954798 | 000 |
| 04961333229932 | K954798 | 000 |
| 04961333231102 | K954798 | 000 |
| 04961333231119 | K954798 | 000 |
| 04961333231171 | K954798 | 000 |
| 04961333242016 | K954798 | 000 |
| 04961333231645 | K954798 | 000 |
| 04961333231638 | K954798 | 000 |
| 04961333231614 | K954798 | 000 |
| 04961333231386 | K954798 | 000 |
| 04961333231362 | K954798 | 000 |
| 04961333231355 | K954798 | 000 |
| 04961333231348 | K954798 | 000 |
| 04961333231331 | K954798 | 000 |
| 04961333231317 | K954798 | 000 |
| 04961333231300 | K954798 | 000 |
| 04961333231188 | K954798 | 000 |
| 04961333229925 | K954798 | 000 |